A new patient registry has been launched for phacoemulsification and intraocular lens implantation procedures, marking a significant advancement in the study of cataract care. This clinical trial, supported by Sensor Cliniq, aims to gather critical insights into the safety and performance of intraocular lenses for cataract patients worldwide.
What changed?
The clinical trial, listed on ClinicalTrials.gov, is actively recruiting participants as of December 12, 2025. This initiative focuses on evaluating the intraocular lens (IOL) devices used to treat patients with cataracts, a leading cause of vision loss globally. The primary objective is to collect robust clinical data that supports better decision-making for medical device manufacturers and healthcare providers.
Trial overview
What is the scope of the trial?
This registry is designed to monitor the use of phacoemulsification, a widely utilized cataract surgery technique, alongside intraocular lens implantation. By tracking patient outcomes over time, the study aims to demonstrate both the safety and effectiveness of the IOL devices in a real-world setting. The findings will play a pivotal role in meeting regulatory standards and advancing evidence-based practices in ophthalmology.
Who is conducting the trial?
The trial is backed by Sensor Cliniq, a recognized sponsor in conducting clinical studies that adhere to stringent regulatory frameworks. Their expertise ensures that all guidelines for patient safety, data integrity, and ethical conduct remain central throughout the study.
Who is impacted?
The outcomes of this trial will provide valuable information for several stakeholders:
- Healthcare Providers: Surgeons and ophthalmologists will benefit from updated clinical data to refine surgical practices and patient selection criteria.
- Device Manufacturers: The findings will support manufacturers in meeting post-market surveillance requirements and optimizing their devices for broader safety claims.
- Regulators: Evidence gathered could inform future policy decisions and reinforce compliance with MDR and FDA guidelines for medical devices.
- Patients: Improved access to safe and effective treatments could enhance patient quality of life by reducing the long-term impact of cataracts.
Frequently Asked Questions
1. What does the trial aim to achieve?
The primary goal is to collect evidence on the safety and performance of intraocular lenses used in cataract surgeries.
2. Who can participate in the trial?
Eligibility specifics are managed by the sponsor, and interested individuals should review the details available on ClinicalTrials.gov.
3. How will the findings be used?
Collected data will inform clinical and regulatory decisions, ensuring the devices meet safety and efficacy standards globally.
Conclusion
The launch of this patient registry marks an essential step in enhancing cataract care standards. By leveraging patient data, manufacturers, providers, and regulators can work collectively to optimize outcomes and safety.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or professional advice. Always consult appropriate regulatory resources for compliance requirements.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07276217?term=medical+device